HUDSON RCI IPN048995Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 14026704617392), received between Feb 2, 2021 and Jul 27, 2023 — classified as 3 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Break” (46 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2023Break; Break

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "THE AIR LEAKING WAS FOUND WHEN THE PATIENT HAD TO BE TURNED AROUND, LEAKING WAS FROM THE BROKEN Y CONNECTOR". THIS OCCURRED DIRECTLY AFTER INTUBATION. THE DEVICE WAS TESTED PRIOR TO USE. A 'JELLY' LUBRICANT WAS USED FOR INTUBATION. THE ISSUE WAS RESOLVED BY CHANGING THE TUBE. NO PATIENT HARM, DESATURATION, OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 17405545 ↗
• MalfunctionJun 9, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100754 ↗
• MalfunctionJun 9, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100749 ↗
• MalfunctionJun 9, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098549 ↗
• MalfunctionMay 30, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "THE DOCTOR FOUND TUBE BLOCKED WHEN USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021112 ↗
• InjuryMay 17, 2023Gas/Air Leak; Gas/Air Leak

  THE REPORT STATES, "THE PATIENT REQUIRED RE-INTUBATION X3 DUE TO BLOWN CUFFS. THE PATIENT DEVELOPED RETROPHARYNGEAL HEMORRHAGE DUE TO THE NUMBER OF INTUBATIONS". ADDITIONAL INFORMATION REGARDING IF A DEVICE WAS USED TO ASSESS CUFF PRESSURE STATES, "NO DEVICE, BUT THE CUFF IS NORMALLY CHECKED PRIOR TO INSERTION". THE PATIENT DID NOT SUSTAIN ANY DESATURATION. PER THE CUSTOMER, IT IS NOT KNOWN HOW THE BLEEDING WAS STOPPED, HOWEVER THE PATIENT DID UNDERGO A BRONCHOSCOPY AFTER THE EVENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO A SKILLED NURSING FACILITY.

  Patient problems: Exsanguination

  MAUDE report 16947919 ↗
• InjuryMay 17, 2023Gas/Air Leak; Gas/Air Leak

  THE REPORT STATES, "THE PATIENT REQUIRED RE-INTUBATION X3 DUE TO BLOWN CUFFS. THE PATIENT DEVELOPED RETROPHARYNGEAL HEMORRHAGE DUE TO THE NUMBER OF INTUBATIONS". ADDITIONAL INFORMATION REGARDING IF A DEVICE WAS USED TO ASSESS CUFF PRESSURE STATES, "NO DEVICE, BUT THE CUFF IS NORMALLY CHECKED PRIOR TO INSERTION". THE PATIENT DID NOT SUSTAIN ANY DESATURATION. PER THE CUSTOMER, IT IS NOT KNOWN HOW THE BLEEDING WAS STOPPED, HOWEVER THE PATIENT DID UNDERGO A BRONCHOSCOPY AFTER THE EVENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO A SKILLED NURSING FACILITY.

  Patient problems: Exsanguination

  MAUDE report 16947886 ↗
• MalfunctionApr 4, 2023Inflation Problem; Inflation Problem

  REPORTED ISSUE: THE DOCTOR FOUND THE CUFF CANNOT BE INFLATED BEFORE USING IT ON THE PATIENT. ANOTHER DEVICE WAS USED AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674519 ↗
• MalfunctionMar 29, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED ISSUE: THE DOCTOR FOUND CUFF LEAKAGE WHEN USING IT ON THE PATIENT. THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637921 ↗
• MalfunctionMar 24, 2023Break; Break

  REPORTED ISSUE: AFTER INTUBATION, WHEN THE CLINICIAN WAS TRYING TO CONNECT WITH Y CONNECTOR, IT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616427 ↗
• MalfunctionMar 24, 2023Break; Break

  REPORTED ISSUE: AFTER INTUBATION, WHEN THE CLINICIAN WAS TRYING TO CONNECT WITH Y CONNECTOR, IT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616183 ↗
• MalfunctionMar 6, 2023Obstruction of Flow; Obstruction of Flow

  REPORTED ISSUE: THE TUBE WAS BLOCKED WHEN USING IT ON THE PATIENT. A NEW TUBE WAS USED AND THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492251 ↗
• MalfunctionFeb 8, 2023Break; Break

  REPORTED EVENT: Y CONNECTOR WAS BROKEN WHEN INITIALLY OPENED.

  Patient problems: Insufficient Information

  MAUDE report 16329107 ↗
• MalfunctionJan 3, 2023Break; Break

  IT WAS REPORTED THAT THE DOCTOR FOUND THE CONNECTOR BROKEN WHILE IN THE CLINICAL SETTING, BEFORE USING IT ON THE PATIENT. A NEW ONE WAS USED. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086817 ↗
• MalfunctionNov 7, 2022Break; Break

  IT WAS REPORTED ON (B)(6) 2022, THAT THE Y-TUBE BROKE OFF DURING USE ON A PATIENT. NO REPORTS OF PATIENT HAVING DESATURATIONS DURING THE TIME OF EVENT. NO PATIENT INJURY OR CONSEQUENCE WAS REPORTED, AND NO MEDICAL INTERVENTION WAS NEEDED. THE CURRENT PATIENT'S CONDITION WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15744346 ↗
• MalfunctionOct 5, 2022Break; Break

  IT WAS REPORTED THAT: "THE NURSE FOUND CONNECTOR BROKEN WHEN OPENING THE PACKAGE BEFORE USING ON PATIENT. THEN CHANGED NEW ONE. NO IMPACT ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543879 ↗
• MalfunctionSep 2, 2022Break; Break

  ALLEGED QUALITY ISSUE/INCIDENT: "THEY CONNECTOR WAS FOUND BROKEN WHEN CLINICAL STAFF OPEN IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348883 ↗
• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED THAT: "THE DOCTOR FOUND CONNECTOR BOKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT. NO IMPACT ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145261 ↗
• MalfunctionApr 14, 2022Break; Break

  IT WAS REPORTED THAT "THE DOCTOR FOUND CONNECTOR BOKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14111165 ↗
• MalfunctionMar 11, 2022Break; Break

  WHEN RECEIVING A COMPLAINT SAMPLE FOR A DIFFERENT EVENT, IN THE SAME PACKAGE, A BROKEN DOUBLE SWIVEL CONNECTOR WAS FOUND. REQUEST FOR ADDITIONAL INFORMATION TO THE CUSTOMER HAS BEEN REQUESTED MULTIPLE TIMES WITH NO RESPONSE. UNKNOWN WHEN THE ISSUE WAS FIRST IDENTIFIED. NO PATIENT INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13733533 ↗
• MalfunctionDec 27, 2021Break; Break

  IT WAS REPORTED "MULTIPLE UNITS BREAKING (Y SWIVEL CONNECTOR ISSUE)". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087380 ↗
• MalfunctionDec 27, 2021Break; Break

  IT WAS REPORTED "MULTIPLE UNITS BREAKING (Y SWIVEL CONNECTOR ISSUE)". NO PATIENT INFORMATION REPORTED. EXACT QUANTITY OF DEFECTED DEVICES NOT REPORTED. REQUEST FOR ADDITIONAL INFORMATION TO THE CUSTOMER HAS BEEN UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 13087355 ↗
• MalfunctionDec 16, 2021Break; Break

  IT WAS REPORTED "DLT CONNECTOR BROKE APART DURING THE CASE. A CONNECTOR WAS TAKEN FROM A NEW DLT AND THE CASE CONTINUED". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022374 ↗
• MalfunctionNov 11, 2021Break; Break

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800259 ↗
• MalfunctionNov 11, 2021Break; Break

  IT WAS REPORTED THAT "THE DOCTOR FOUND CONNECTOR BROKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800229 ↗